four pages) Other Biographical Sketches (Not to exceed four pages for each - Seeinstructions) Resources 33 Research Plan. 33 Introduction to Revised Application (Not to exceed 3 pages) 33 Introduction to Supplemental Application (Not to exceed one page) N/A A. Specific Aims 36 B. Background and Significance 37 C. Preliminary Studies/Progress Report/ (Items A-D: not to exceed 25 pages*) 44 Phase I Progress Report (SBIR/STTR Phase II ONLY) * SBIR/STTR Phase I: Items A-D limited to 15 pages. D. Research Design and Methods 50 E. Human Subjects 58 Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") 58 Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") _58 Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes") _58 Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") 58 Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "Yes" and a Phase I, II, or III clinical trial is proposed F. Vertebrate Animals 60 G. Literature Cited 60 H. Consortium/Contractual Arrangements 66 I. Letters of Support (e.g., Consultants) 68 J. Product Development Plan (SBIR/STTR Phase II and Fast-Track ONLY) N/A Checklist. 69 Check if Appendix (Five collatedsets. Nopage numbering necessary for Appendix.) Appendix is Included Appendices NOT PERMITTED for Phase I SBIR/STTR unless specifically solicited.... Number of publications and manuscripts accepted for publication (notto exceed10) Other items (list): 1. Letter of support: Prof. John DeLuca, consultant PHS 398 (Rev. 05/01) Page. Form Page 3 Use /2-inch MARGINS. Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b.